Food and Drug Law Commons^™

A Fresher Law: Amending The Florida Right To Farm Act To Include Urban Micro Farming As A Key Initiative To Promote Sustainability, Food Access, And Environmental Justice For Low-Income Communities, Cameryn Rivera

Florida A & M University Law Review

No abstract provided.

Good Policy, Good Food: Bringing A Just And Sustainable Food System To All, Mark Winne

Florida A & M University Law Review

No abstract provided.

The Crisis Of Over-Medicating Children In Foster Care: Legal Reform Recommendations For New York, Jessica Setless

Cardozo Journal of Equal Rights & Social Justice

No abstract provided.

Front-Of-Package Nutrition Claims: Trustworthy Facts Or Deceptive Marketing? Closing The Loopholes In Labeling, Kathryn E. Hayes

Cardozo Journal of Equal Rights & Social Justice

The note argues that front-of-package (FOP) labeling on children's food products is insufficient and often misleading, failing to meet basic nutritional standards. It advocates for the adoption of uniform, science-based labeling standards developed by an objective body like the Institute of Medicine (IOM) to help parents make healthier choices. The analysis highlights the limitations of self-regulation by manufacturers and the need for stronger governmental oversight to address deceptive practices and improve public health outcomes.

Preemption Under The Controlled Substances Act, Robert A. Mikos

Vanderbilt Law School Faculty Publications

States are conducting increasingly bold experiments with their marijuana laws, but questions linger over their authority to deviate from the federal Controlled Substances Act. The CSA bans marijuana outright, and commentators have assumed that Congress sought to preempt all state laws that might somehow conflict with the CSA. Under the preemption rule now in vogue, state marijuana reforms are preempted if they either require someone to violate the CSA or, more controversially, if they pose an obstacle to Congress’s objective of eradicating marijuana. Seeking to avoid such conflicts, government officials have scuttled a number of important state marijuana reforms. This …

Do Graphic Tobacco Warnings Violate The First Amendment?, Nathan Cortez

Faculty Journal Articles and Book Chapters

When Congress passed the nation’s first comprehensive tobacco bill in 2009, it replaced the familiar Surgeon General’s warnings, last updated in 1984, with nine blunter warnings. The law also directed the U.S. Food and Drug Administration ('FDA') to require color graphics to accompany the textual warnings. By law, the warnings would cover the top fifty percent of the front and back of tobacco packaging and the top twenty percent of print advertisements, bringing the United States closer to many peer countries that now require graphic warnings. Tobacco companies challenged the requirement on First Amendment grounds, arguing that the compelled disclosures …

The Future Of Gene Patents And The Implications For Medicine, Jacob S. Sherkow, Henry Greely

Other Publications

The Supreme Court decision in Myriad Genetics struck down the patenting of human genomic DNA. What will this mean for genetic testing and medicine, more broadly?

Pay-To-Play: The Impact Of Group Purchasing Organizations On Drug Shortages, Christian Deroo

American University Business Law Review

No abstract provided.

Adjustments, Extensions, Disclaimers, And Continuations: When Do Patent Term Adjustments Make Sense?, Stephanie Plamondon Bair

Faculty Scholarship

The United States patent system represents a measured trade-off between two competing policy considerations: providing sufficient incentives to encourage the innovation and development of new and socially useful inventions; and ensuring that such inventions are readily available to the public at an affordable price. Although the default patent term is now twenty years from filing, various features of, and changes to, the patent system over the years have allowed patent owners to extend the duration of their patent monopolies, sometimes for several years. Such extensions, though seemingly insignificant when compared to the full patent term, have an enormous impact on …

The Paradox Of Legal Equivalents And Scientific Equivalence: Reconciling Patent Law's Doctrine Of Equivalents With The Fda's Bioequivalence Requirement, Janet Freilich

Faculty Scholarship

Contrary to popular perception, generic drugs often enter the market before the patents covering their brand name counterparts have expired by making slight changes to the drug to avoid the brand name patent. These generics face a paradox: the U.S. Food and Drug Administration (FDA) requires that the generic "not show a significant difference" from the reference product, while patent law requires that the generic have "substantial differences" as compared to the reference product. The generic must be bioequivalent, but not legally equivalent, to the brand name drug. This paradox occurs frequently in the courts but has never been discussed …

Who’S Your Nanny, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

INTRODUCTION: In June 2012, New York City Mayor Michael Bloomberg announced his plans for a ban on the sale of sugary beverages in containers larger than 16 ounces. Shortly thereafter, the Center for Consumer Freedom took out a full-page ad in the New York Times featuring Bloomberg photo-shopped into a matronly dress with the tag line "New Yorkers need a Mayor, not a Nanny."1 On television, the CATO Institute's Michael Cannon declared, "This is the most ridiculous sort of nanny state-ism; [ilt's none of the mayor's business how much soda people are drinking." And in news- papers around the country, …

Review, Risk, Legality And Damages, Paul Craig

Articles by Maurer Faculty

No abstract provided.

International Law In A Time Of Scarcity: An Introduction, Harlan G. Cohen

Faculty Scholarship

Stories of scarcity litter the morning newspapers. Around the world, resources — food, water, fuel sources, clean air — seem stretched to, or even beyond, capacity. Consequences have already been serious, including suffering and unrest. Competition for resources seems likely only to increase. Does international law have the tools to manage or even solve this growing global problem? It was with this question in mind that the editors of the Georgia Journal of International and Comparative Law convened their 2012 symposium: “International Law in a Time of Scarcity.”

This short essay serves as introduction to that symposium and the related …

Undue Process At The Fda, Lisa Heinzerling

Georgetown Law Faculty Publications and Other Works

For over 40 years, the Food and Drug Administration has been collecting evidence that the routine administration of antibiotics to animals destined for the food supply contributes to the development of antibiotic-resistant infections in the human population. For all these years, the FDA has put off acting with any force on this health risk. The agency’s explanation has been that the Food, Drug and Cosmetic Act requires it to hold time- and resource-intensive formal hearings before it can withdraw approvals for antibiotics used for the purposes of promoting growth and preventing infection in food animals. In so arguing, the FDA …

Pay-To-Delay Settlements: The Circuit-Splitting Headache Plaguing Big Pharma, Shannon U. Han

Vanderbilt Journal of Entertainment & Technology Law

At its passage, the Hatch-Waxman Act was hailed as a much-needed step in making generic drugs more readily available to consumers, easing some of the heavy burdens placed on consumers by the necessary, but flawed, patent system that essentially granted brand-name pharmaceutical manufacturers a de facto economic monopoly over their drugs. One consequence of the Act, unforeseen by legislators and regulators, was the creation of a perverse incentive on behalf of pharmaceutical patent holders to pay alleged patent infringers substantial cash payments to delay entry into the particular drug market. These pay-to-delay settlements--or reverse-payment settlements--have been at the center of …

Frameworks For Amending Reservoir Water Management, Ethan Mower, Leandro E. Miranda

Publications

Managing water storage and withdrawals in many reservoirs requires establishing seasonal targets for water levels (i.e., rule curves) that are influenced by regional precipitation and diverse water demands. Rule curves are established as an attempt to balance various water needs such as flood control, irrigation, and environmental benefits such as fish and wildlife management. The processes and challenges associated with amending rule curves to balance multiuse needs are complicated and mostly unfamiliar to non-US Army Corps of Engineers (USACE) natural resource managers and to the public. To inform natural resource managers and the public we describe the policies and process …

Archival: A Water Rights Manual For Mutual Domestic Water Consumers Associations, Utton Center, University Of New Mexico - School Of Law, Zackeriah Carpenter, Gregory Chakalian, Darcy S. Bushnell

Publications

The Utton Center prepared this Water Rights Manual to assist Mutual Domestic Water Consumers Associations (MDWCAs) with the development, protection and management of their water rights.

This manual provides an introduction to and defines Water Rights in New Mexico, as well as to acquire and have recognized Water Rights. This document also covers water management and planning, and provides additional resources.

Check Please: Using Legal Liability To Inform Food Safety Regulation, Alexia Brunet Marks

Publications

Food safety is a hotly debated issue. While food nourishes, sustains, and enriches our lives, it can also kill us. At any given meal, our menu comes from a dozen different sources. Without proper incentives to encourage food safety, microbial pathogens can, and do enter the food source--so much so that according to the Centers for Disease Control and Prevention (CDC), each year roughly one in six Americans (or forty-eight million people) gets sick, 128,000 are hospitalized, and 3,000 die of foodborne diseases. What is the optimal way to prevent unsafe foods from entering the marketplace?

Safety in the food …

Shame, Blame, And The Emerging Law Of Obesity Control, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

In using law as a tool to combat the obesity epidemic, legal scholars and policymakers are drawing heavily on the lessons of tobacco control. This Article describes the resulting emergence of "obesity control law" and argues for a radical reorientation of it from a "denormalization" strategy based on the tobacco control experience to a "destigmatization" strategy based on the HIV prevention experience. The war on obesity is nearing a political crossroads. Subsidies and food industry regulations aimed at making our environment more conducive to physical activity and healthy eating are in danger of losing out to cheaper and more politically …

The U.S. Department Of Agriculture As A Public Health Agency, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

Introduction: The "war on obesity" is now well into its second decade.' What began as an effort to encourage medical doctors to screen and treat patients whose weight put them at risk for health problems has transformed into a much broader public health campaign to address the root causes of obesity. A growing number of state, territorial and local health departments are currently exploring new ways to promote healthy eating and physical activity. At the federal level, the U.S. Centers for Disease Control and Prevention (CDC) has made "nutrition, physical activity and obesity" a top priority.

Selected Bibliography On Adjudications And New Mexico Water Management, Carol Romero-Wirth, Susan Kelly, Ernesto Longa

Publications

No abstract provided.

The Special Supplemental Nutrition Program For Women, Infants, And Children (Wic) And The Supplemental Nutrition Assistance Program (Snap): Comparing Policies And Suggesting Changes, Regina T. Cucurullo

Journal of Food Law & Policy

National concerns, such as obesity, should be addressed through national efforts. Considering the national reach of the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) and the Supplemental Nutrition Assistance Program (SNAP) and their ability to influence the diets of a significant amount of the nation's population, changes to these programs should be made to encourage healthy nutrition.

Food And Agricultural Security Strategy And Its Implementation Under Public Health Security And Bioterrorism Preparedness And Response Act Of 2002, Vivek V. Nemane

Journal of Food Law & Policy

The U.S. agricultural system can be described as concentrated, specialized and industrialized. A typical food chain generally involves agricultural production, storage, processing and distribution. In the U.S. agricultural and food system, most production, distribution and processing is done in a consolidated and centralized manner.

Food Sovereignty In The United States: Supporting Local And Regional Food Systems, Allison Condra

Journal of Food Law & Policy

Today, perhaps more than ever, an increasing portion of U.S. society is paying attention to and asking questions about our food and agricultural system. We are recognizing the immense consequences of the agricultural "efficiencies" we valued and wrote into our policies in the seventies-for example, growing corn "fence row to fence row" and the ease of microwaved meals and prepackaged foods. 3 The increasingly global nature of our food system and its consequences are becoming more apparent. Food safety concerns-prompted by a growing number of foodborne illness outbreaks and the government's response in the 2009 Food Safety Modernization Act-loom large …

The Real Toy Story: The San Francisco Board Of Supervisors Healthy Food Incentives Ordinance, Cortney Price

Journal of Food Law & Policy

Obesity among children in the United States has tripled over the last thirty years. Incidentally, the world's largest fast food restaurant, McDonald's, first introduced its children's Happy Meal thirty-two years ago. Shortly thereafter, the first Disney inspired toy found its way into Happy Meals and the hearts of the "billions and billions served." Although the iconic Happy Meal and accompanying toy have become "a staple of Americana akin to baseball and apple pie," the continued existence of the practice is being threatened in light of the powerful influence toys have on children's food choices, thus contributing to the current obesity …

Cash, Crops, Chemicals, And Cosmetics: A Mid-Green Eco-Labeling Approach, Michael T. Olexa, R. Benjamin Lingle, Kimberly Stewart, Damian C. Adams

Journal of Food Law & Policy

The United States Department of Agriculture (USDA) uses grade standards to uniformly characterize the quality and condition of agricultural commodities. The standards are promulgated by the USDA's Agricultural Marketing Services (AMS) division in consultation with farming industry groups. Emphasizing produce attributes such as surface defects, shape, cleanliness, color, maturity, and decay, grade standards improve the marketability of agricultural commodities by establishing a common industry language for use in contracts. Use of such a language enables wholesale buyers to know the quality of commodities without first having to inspect them, thus facilitating trade by lowering transaction costs.

Medical Evidence In Cases Of Intrauterine Drug And Alcohol Exposure , Judith Larsen, Robert M. Horowitz, Ira J. Chasnoff

Pepperdine Law Review

No abstract provided.

Vaccines And The Law, Michael Sanzo Ph.D.

Pepperdine Law Review

The last twenty years have seen a sea-change in the area of proving causation in the toxic tort setting, with courts demanding stronger, scientifically tested evidence. At the same time, a closely related debate has been raging about separating cause from coincidence under the National Childhood Vaccine Injury Act compensation program for injuries that might have been the result of vaccinations. The Vaccine Act created a no-fault compensation fund financed by a tax on childhood vaccines to address harms resulting from those vaccines. Unfortunately, Congress gave little direction with regard to the level of causal certainty that would be required …

Executives Should Think Twice Before Accepting Pleas 'Related To Fraud': The Expansion Of Exclusion Under The Park Doctrine, Abraham Gitterman

Student Articles and Papers

No abstract provided.

Water Rights Management In New Mexico And Along The Middle Rio Grande: Is Awrm Sufficient?, Carol Romero-Wirth, Susan Kelly

Publications

No abstract provided.